Covid-19 Infection and Pulmonary Distress Treatment With Zanubrutinib in Hospitalized Participants
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ClinicalTrials.gov Identifier: NCT04382586 |
Recruitment Status :
Completed
First Posted : May 11, 2020
Results First Posted : March 2, 2022
Last Update Posted : March 2, 2022
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Condition or disease | Intervention/treatment | Phase |
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COVID-19 Pulmonary Complications COVID-19 | Drug: Zanubrutinib Drug: Supportive Care Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 63 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Phase 2, Randomized, Double Blind, Placebo-Controlled Study of Zanubrutinib Treatment in Patients Hospitalized for COVID-19 Infection and Pulmonary Distress |
Actual Study Start Date : | July 6, 2020 |
Actual Primary Completion Date : | February 1, 2021 |
Actual Study Completion Date : | February 1, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Zanubrutinib + Supportive Care
Participants received zanubrutinib plus supportive care
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Drug: Zanubrutinib
320 mg (4 x 80 mg) capsules administered orally once daily
Other Names:
Drug: Supportive Care Supportive care treatment was selected and administered as deemed appropriate by the study investigator |
Active Comparator: Placebo + Supportive Care
Participants received placebo plus supportive care alone
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Drug: Supportive Care
Supportive care treatment was selected and administered as deemed appropriate by the study investigator Drug: Placebo Placebo to match zanubrutinib |
- Number of Participants With Respiratory Failure-free Survival [ Time Frame: Up to Day 28 ]Number of participants with respiratory failure-free survival, defined as not having died or gone into respiratory failure on or before Day 28
- Time to Breathing Room Air [ Time Frame: Up to 7 months ]Time to return to breathing room air is defined as the time from randomization date to the earliest time where the participant is stable on room air without supplemental oxygen. Total follow-up time in days is the total time of all participants from the randomization date to the first event date or Day 28 if there is no event. The rate was calculated as total number of events in which a participant returned to breathing room air on or before Day 28 divided by the total follow-up time in days.
- Number of Participants Experiencing Respiratory Failure or Death [ Time Frame: Up to Day 28 ]Number of participants experiencing respiratory failure or death on or before Day 28
- Number of Participants With All-cause Mortality [ Time Frame: Up to Day 28 ]Number of participants with all-cause mortality on or before Day 28
- Number of Participants Discharged Alive [ Time Frame: Up to Day 28 ]Number of participants discharged alive on or before Day 28
- Number of Participants Discharged Alive From the ICU [ Time Frame: Up to Day 28 ]Number of participants discharged alive from the intensive care unit (ICU) on or before Day 28
- Number of Participants With Improvement in the World Health Organization (WHO) 8-point Ordinal Scale [ Time Frame: Up to Day 28 ]Number of participants with improvement in WHO 8-point-scale, in which improvement was considered a score that changed from ≥4 at baseline to ≤ 3 at Day 28 as assessed by the investigator. Scoring ranges from 0 = uninfected with no clinical or virologic evidence of disease to 8 = dead.
- Duration of Mechanical Ventilation [ Time Frame: Up to Day 28 ]Number of days on mechanical ventilation on or before Day 28
- Duration of Hospitalization [ Time Frame: Up to Day 28 ]Number of days hospitalized on or before Day 28
- PaO2:FiO2 Ratio [ Time Frame: Baseline, Day 7, Day 14, Day 21 and Day 28 ]Partial pressure of oxygen (PaO2):fraction of inspired oxygen (FiO2) ratio
- Number of Participants With Adverse Events [ Time Frame: Up to 7 months ]Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), treatment-related adverse events (AEs), and TEAEs grade 3 or higher, including laboratory findings

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
- Hospitalization for COVID-19 infection
- Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by polymerase chain reaction (PCR)
- Participant requires supplemental oxygen for pulmonary distress related to COVID-19 infection, and has been on supplemental oxygen for no more than 96 hours from time of screening
Key Exclusion Criteria:
- Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, symptomatic inflammatory bowel disease or ulcerative colitis, or partial or complete bowel obstruction
- On a Bruton's tyrosine kinase (BTK) inhibitor
- Planned or concurrent use of a host modifiers/immune-based therapies or anti-CD20 monoclonal antibody treatment
- Participants with prior of current hematologic malignancy or solid tumor malignancy with treatment within 6 months prior to study entry
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04382586

Principal Investigator: | Study Director | BeiGene |
Documents provided by BeiGene:
Responsible Party: | BeiGene |
ClinicalTrials.gov Identifier: | NCT04382586 |
Other Study ID Numbers: |
BGB-3111-219 |
First Posted: | May 11, 2020 Key Record Dates |
Results First Posted: | March 2, 2022 |
Last Update Posted: | March 2, 2022 |
Last Verified: | February 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Corona Virus COVID-19 |
COVID-19 Infections Respiratory Tract Infections Pneumonia, Viral Pneumonia Virus Diseases Coronavirus Infections Coronaviridae Infections Nidovirales Infections |
RNA Virus Infections Lung Diseases Respiratory Tract Diseases Zanubrutinib Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |